Clinical Trial
Progressing a New Class of Imaging Agents Through Clinical Development
MagSense® HER2 Imaging Agent (MSH2IA) Phase II Clinical Study – IND Number 165081
Imagion Biosystems is pleased to announce that the U.S. Food and Drug Administration (FDA) has issued a Study May Proceed Notice for the Company’s Investigational New Drug (IND) application. The FDA’s allowance to proceed with the Phase 1b/2 clinical study in HER2+ breast cancer patients indicates that the company has comprehensively addressed all necessary logistical, analytical, quality and safety pre-requisites necessary to conduct the trial.
Next Steps
The Company is moving forward with plans to initiate the Phase 1b/2 clinical trial for the MagSense® HER2 Imaging Agent in individuals with HER2+ breast cancer, and anticipates patient recruitment to commence during the third quarter of 2026, following site activation. The Company has pre-selected and engaged necessary strategic trial partners required to manage the study.
Phase 1b/2 Clinical Trial Design
Designed in three parts, the trial will start with an initial cohort of subjects to collect additional safety data (Part A), as agreed with the FDA. The reduced dosing regimen and optimised imaging protocol will then be evaluated in a second group of subjects (Part B) before proceeding to a larger cohort of subjects to establish diagnostic performance (Part C). The trial for the MagSense® Imaging Agent in HER2+ Breast Cancer is expected to be completed in 18-24 months, with interim analyses anticipated after Part A and after Part B. In addition to evaluating the diagnostic performance of MagSense® for HER2+ breast cancer, the results of the trial will provide valuable insight into the potential impact on cost of care, patient outcomes, and overall clinical value. Additionally, by integrating quantitative imaging techniques into the protocol, the trial will yield critical data for the development and training of AI diagnostic tools.
Why is the MagSense® HER2 Imaging Agent Phase 2 Trial important?
Each year, approximately 450,000 women receive a HER2 positive (HER2+) breast cancer diagnosis globally.1 A HER2+ classification has significant prognostic and predictive implications for the patient because the HER2-positive subtype is considered an aggressive phenotype with a high rate of recurrence and metastasis. After a new cancer diagnosis, nodal staging is performed, which is a process that evaluates whether cancer has spread to nearby regional lymph nodes and involves a combination of clinical assessment and radiographic imaging. Precise nodal staging is an essential component in the management of patients with breast cancer, as treatments depend on patient specific characteristics of the primary tumour, nodal status, and evaluation for distant metastatic disease. There are variable practice patterns and imaging modalities employed based on available resources and institutional experience. The most commonly employed method is ultrasound, and whilst convenient and potentially lower cost compared to MRI, it faces a number of diagnostics challenges, resulting in wide variability in both sensitivity and specificity, as well as the limited ability to scan for the extent of the disease spread. Therefore, accurate nodal assessment to support early cancer diagnosis represents a critical unmet need.
About the MagSense® Imaging Agent Technology
Imagion is the first company developing molecularly targeted cancer specific imaging agents for use with MRI. MagSense® technology is a new class of MRI imaging agents that improves cancer detection compared to conventional imaging technologies by adding molecular specificity without using radioactivity. MagSense® agents will be the first imaging technology to use targeted magnetic nanoparticles to tag and detect cancers allowing for visualisation using MRI. This new class of imaging agents does not use ionising radiation or radioactive tracers and improves how medical imaging can be used compared to conventional imaging methods which only identify a region of interest using anatomical or morphological features but cannot differentiate benign tumours from malignant cancer.
Clinicians and institutions interested in becoming an investigator or study site should contact info@imagionbio.com to learn more.
If you are interested in learning more, please contact Imagion Biosystems
MagSense® HER2 Imaging Agent (MSH2IA) Phase I Clinical Study – IBI010103
Imagion Biosystems has concluded an investigational Phase I study of a novel molecular imaging agent. This first-in-human study investigated the safety of the MagSense® HER2 Imaging Agent (MSH2IA) and the feasibility of MRI detection of metastatic disease in the axillary nodes in patients with HER2-positive (HER2+) primary breast cancer.
MSH2IA is specifically designed for breast cancer patients who test positive for the Human Epidermal Growth Factor Receptor 2 (HER2). This study has shown that this molecular MRI contrast agent is safe and has the potential to non-invasively determine if breast cancer has spread to the lymph nodes.
Details of the study can be found at Australia New Zealand Clinical Trial Registry
See our most recent data from the SABCS 2023 scientific poster.
